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A pill instead of surgery? trial tests vepugratinib against Low-Grade bladder cancer

NCT ID NCT07827612

Disease control Sponsor: Eli Lilly and Company Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 18, 2026 · Last updated Sep 18, 2026

Summary

Researchers are testing whether an oral drug called vepugratinib can clear low-grade, intermediate-risk bladder cancer that has not invaded muscle, or low-grade upper tract urothelial cancer. The trial enrolls adults whose tumors carry a specific change in the FGFR3 gene. Participants receive the drug by mouth, and doctors check for complete response using scopes and urine tests. The study also tracks how long any response lasts and whether tumors return.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
an experimental oral drug called vepugratinib
What this could lead to
If it works, vepugratinib could offer a pill-based option for people with low-grade bladder or upper tract tumors that carry FGFR3 changes, possibly avoiding repeated surgeries.
What could go wrong
This is a phase 2 trial, so researchers do not yet know if the drug clears tumors or how long any response lasts. Oral FGFR inhibitors can cause side effects such as high phosphate levels, skin changes, and eye problems, and not every tumor with an FGFR3 change will respond.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 161 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Dec 2026

An estimate. Start dates often move.

Expected to finish

Mar 2031

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * All Participants: * Have a PS of 0 to 2 on the Eastern Cooperative Oncology Group Performance Status (ECOG PS) scale * Cohort A * Have histologically confirmed LG NMIBC. * Have LG IR NMIBC at time of screening * Have a documented qualifying fibroblast growth factor receptor 3 protein (FGFR3) mutation or fusion * Cohort B * Have histologically confirmed LG UTUC. Exclusion Criteria: * All Participants * Have had a prior positive urine cytology within 6 weeks of first day of treatment. * Have received prior local instillation (for example, intravesical chemotherapy, Bacillus Calmette-Guerin, Jelmyto) therapy within 8 weeks of the first day of treatment. * Cohort A * Have synchronous UTUC disease. * Have presence of, or history of, high-grade urothelial carcinoma within 3 years of the first day of treatment, or presence of, or history of, carcinoma in situ. * Cohort B * Have presence of bladder tumors at the time of enrollment. * Have presence of, or history of, high-grade urothelial carcinoma or carcinoma in situ.

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Conditions

The condition(s) this trial relates to.

benign urinary system neoplasm urinary bladder neoplasm Urinary Bladder Neoplasms urinary system neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Receptor, fibroblast growth factor, type 3 Urinary bladder neoplasms Urologic neoplasms

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Carolina Urologic Research Center, LLC

    Myrtle Beach, South Carolina, 29572, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.